V-Trak 100308HS-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777020680), received between Jan 2, 2018 and Jul 30, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE UNCONNECTED COIL IN THE RIGHT POSITION OF THE ANEURYSM. THE PROCEDURE WAS SUCCESSFULLY FINISHED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256955 ↗
• MalfunctionFeb 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL DETACHED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382658 ↗
• InjuryJan 2, 2018Difficult To Position; Difficult to Remove; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED ON A MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM. AFTER PLACEMENT OF THE COIL, THE BALLOON WAS DEFLATED AND THE COIL PROLAPSED INTO THE PARENT ARTERY. DURING THE ATTEMPT TO RESHEATH AND REMOVE THE COIL, A LOT OF RESISTANCE WAS ENCOUNTERED. AFTER TWO ADDITIONAL ATTEMPTS WERE MADE, THE COIL WAS WITHDRAWN ENTIRELY INTO THE MICROCATHETER; HOWEVER, BY THIS TIME, SOME THROMBUS WAS IDENTIFIED AT THE NECK OF THE ANEURYSM. NO MORE COILS WERE DEPLOYED. THE CLOT WAS RESOLVED AFTER ADMINISTERING 6 ML OF AGGRAMED, AND THE PROCEDURE WAS STOPPED. THE PATIENT WAS REPORTED TO HAVE SLIGHT HEMIPARESIS. THE DAY AFTER THE PROCEDURE, A CT REVEALED A SMALL INFARCT NEAR THE TEMPORAL LOBE. THE PATIENT'S CONDITION IMPROVED TWO (2) DAYS LATER AND SHE WAS DISCHARGED. THE PATIENT IS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Infarction, Cerebral; Paresis; Thrombus

  MAUDE report 7158377 ↗